510(k) K911459 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
| Applicant | Fresenius USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Jul 17, 1991 |
| Received | Apr 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911459
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2015 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101.
For Use in the Preparation of acid concentrate for hemodialysis. Terminated |
KPO | None listed |
| Aug 15, 2010 | Fresenius Medical Care North America Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.